Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.
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Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease.
At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success.
Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands.
We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.
Summary of Role
The Sr. Research Scientist reports to the Sr. Director of Pharmaceutical Development and will conduct analytical studies to support the Research and Pharmaceutical Development (R&PD) portfolio of new and existing products.
Requirements include technical expertise in method development / validation, optimization and troubleshooting of analytical issues, interaction with and transfer of analytical methods to Contract Manufacturing Organizations (CMO), and competency in the use of HPLC, UV, radio-detection, LCMS, GC and other methodologies.
Analytical analysis of both research and commercial products is required including gamma radioactive samples. Communication with contract research organizations is required for external studies using R&PD test compounds.
Data interpretation, issue resolution as needed, and report writing is also required.
This position, based in North Billerica, will provide wide-ranging technical support to internal departments and external product manufacturing facilities (PMFs) and CMOs with extensive laboratory expertise and experience.
The qualified candidate must be self-directed, be a great team player, and have excellent communication skills.
Essential Functions
- Develop / write procedures, and document results in notebook and report formats.
- Troubleshoot problems with a range of equipment, procedures and, or automated systems. Accurately describe results to internal work groups.
- Draft the CMC sections for the IND, IMPD, CTA, and NDA submission.
- Apply an ability to evaluate data, identify unusual results and design studies that address or expand the understanding of the process being studied.
- Accurately document results in established formats. Write reports on all phases of laboratory and / or field experimental work with limited direction.
- Actively promote safety rules and awareness. Always demonstrate good safety practices including the appropriate use of protective equipment.
Report and take initiative to correct safety and environmental hazards.
- Work with minimal supervision to achieve personal objectives, department, and company goals.
- Provide technical guidance to resolve analytical methods issues, conduct OOT / OOS investigations, identify, and improve problematic analytical methods.
- Participate in and contribute to projects across organizational departments : method validations and method transfer to MTD.
- Maintain laboratory notebook, record keeping, and laboratory safety in accordance with common industry GMPs and Lantheus procedure.
Basic Qualifications
- Degree in Chemistry, Pharmaceutical, Engineering, or equivalent with a fundamental understanding of the technical aspects of analytical chemistry and pharmaceutical process development.
- Requires a Ph.D. degree and 5+ years relevant work experience, a M.S. degree and 10+ years relevant work experience OR a B.
S. degree and 15+ years relevant work experience in the pharmaceutical industry.
- Demonstrated experience with equipment / automation systems (e.g., HPLC, UV, GC, MS, radio-detectors). Authors protocols and close-out reports.
- Expertise in the logical design and review of analytical, pharmaceutical and / or validation experiments.
- Strong organizational, presentation and communication skills, both written and verbal.
- Experience working in a GxP pharmaceutical environment is a plus.
- Strong analytical development and problem-solving skills.
Other Requirements
Requires the handling of, and / or exposure to, potentially hazardous chemical, radiological and or biological materials.
Required to follow all safety procedures, and to use personal and protective equipment provided.
- Travel may be required as per business need.
- This position is site-based and requires a presence on-site of 5 days per week in Billerica, MA when not traveling.
Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.
Lantheus is an E-Verify Employer in the United States. Lantheus will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and / or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at [email protected].
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